Mega Soft

Basic Information

• Brand Name: Mega Soft
• Primary DI: 10614559105221
• Version / Model: M2K06
• Catalog Number: M2K06
• Company Name: MEGADYNE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 185444825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-05
• Public Version: 10
• Public Version Date: 2023-05-12
• Public Version Status: Update
• Public Device Record Key: 3814b771-14b4-4feb-b258-ddfeb4cfc230

Device Description

Mega Soft Argon Beam Cable 2.4m (8'-0")

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63401	Electrosurgical return lead	An insulated metal wire(s) intended to connect an electrosurgical return electrode (not included) to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during monopolar electrosurgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10614559105221	GS1
Package	30614559105225	GS1	CASE	40	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080741	000
K133726	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius